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Drug Safety Labeling Changes - January 2012

Food and Drug Administration (FDA) announces important safety label changes for prescription drugs almost every month. By implementing the label changes the FDA warns a physician of new side- effects, adverse reactions, contra-indications and precautions necessary for a drug. This information is important for safe practice of medicine.

Key to Label Sections

  • C - Contraindications
  • W - Warnings
  • P - Precautions
  • AR - Adverse Reactions
Drug Name Sections Modified
C W P AR
Aliskiren
Aliskiren and Amlodipine
Aliskiren and hydrochlorothiazide
Aliskiren and valsartan
Aliskiren, Amlodipine and Hydrochlorothiazide
Amlodipine and Benazepril
Amlodipine and Olmesartan
Amlodipine and Valsartan
Amlodipine, Valsartan and Hydrochlorothiazide
Azacitidine
Azelastine
Benazepril
Benazepril HCl and Hydrochlorothiazide
Bromocriptine
Bupropion
Cetuximab
Clindamycin
Clozapine
Colesevelam Hcl
Dabigatran
Darifenacin
Dronedarone
Eprosartan
Eprosartan Mesylate Hydrochlorothiazide
Esomeprazole
Ezetimibe
Ezetimibe and simvastatin
Fenofibric Acid
Formoterol
Gabapentin
Hydroxyurea
Iloperidone
Irbesartan
Irbesartan and Hydrochlorothiazide
Leuprolide
Moexipril HCl Hydrochlorothiazide Tablets
Morphine
Nafarelin
Naproxen and Esomeprazole Magnesium
Orlistat
Quinapril
Quinapril HC- Hydrochlorothiazide Tablets
Ramipril
Solifenacin
Telmisartan
Telmisartan and Amlodipine
Trandolapril
Trandolapril- Verapamil
Valsartan
Valsartan and Hydrochlorothiazide
Varenicline
Zonisamide

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes

Drugs A-Z
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